Mortalite Infantile Reduite Par l'Administration de Masse de l'Azitromycine
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 入组人数
- 694,400
- 试验地点
- 3
- 主要终点
- All-cause mortality
研究概览
简要总结
This trial will investigate the supplementation of azithromycin distribution to the "Child Health Days" platform in Burkina Faso for child mortality reduction. This distribution will pair door-to-door administration of vitamin A and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.
详细描述
The MORDOR clinical trial funded by the Bill & Melinda Gates Foundation in Malawi, Tanzania, and Niger demonstrated that biannual oral azithromycin distributions to children aged 1-59 months significantly reduced child mortality. The investigators hypothesize that biannual administration of azithromycin to children aged 1-11 months will reduce mortality in this age group. The aim of the project is to demonstrate that this intervention can be scaled up and produce the same benefits on mortality as those documented in smaller, more controlled studies. Since 1986, to reduce child mortality, Burkina Faso has been administering high-dose vitamin A supplementation to children aged 6-59 months on a biannual basis through the "Child Health Days" platform. The "Child Health days" are a door-to-door distribution of vitamin A coupled with screening for acute malnutrition in children aged 6-59 months and deworming of children aged 12-59 months. This approach has been successful but expensive. A new strategy implemented since September 2017 relies on community-based health workers (CBHWs) to distribute Vitamin A in rural areas, and on community-based distributors (CDs) in urban areas. Based on expert opinion and the preliminary findings of formative research conducted by the Ministry of Health and Helen Keller International, it was agreed that the Child Health Days platform was the most appropriate platform to implement the biannual administration of azithromycin to children aged 1 to 11 months.
In this trial, mortality will be measured via complete birth history which will be collected in a subset of villages in the study area before the first treatment distribution. The study team will also conduct a baseline census of the study areas for treatment coverage estimations.
Sixty villages (30 azithromycin, 30 placebo) will contribute to the macrolide resistance outcomes, where the study team will collect rectal and nasal swabs from children 1-59 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This will be a quadruple blinded study. Only one biostatistician and one analyst at UCSF will have the unmasking information.
入排标准
- 年龄范围
- 1 Month 至 11 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Community eligibility criteria:
- •Located in one of the three selected regions: SudOuest, Centre-Ouest, Hauts-Bassins
- •Verbal consent of the community leader is obtained
- •Inclusion criteria for children:
- •Aged 1 to 11 months
- •Living in one of the communities participating in the study
排除标准
- •Community exclusion criteria:
- •Inaccessible or unsafe for the study team
- •Exclusion criteria for children:
- •Known allergy to macrolides
研究组 & 干预措施
Biannual mass oral azithromycin + child health days
Bi-annual Mass Azithromycin distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform
干预措施: Azithromycin (Drug)
Biannual mass placebo + child health days
Bi-annual Mass placebo distribution to all children 1-11 months old in participating communities paired with the Child Health Days Vitamin A distribution platform
干预措施: Placebo (Drug)
Resistance Sub Study: Azithromycin + Child Health Days
Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion
干预措施: Azithromycin (Drug)
Resistance Sub Study: Placebo + Child Health Days
Antimicrobial resistance will be monitored in a parallel study of communities from the target study area. 60 communities will be randomly selected among eligible communities, and randomized in a 1 : 1 fashion
干预措施: Placebo (Drug)
结局指标
主要结局
All-cause mortality
时间窗: 24 months following baseline
a) Evaluate whether azithromycin integrated within the VAD+ platform reduces mortality in children aged 1-11 months old compared to placebo
次要结局
- Antimicrobial Resistance (AMR)(24 months)
- Clinic Visits(24 months)
